{"commentary":{"count":181,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":90,"youtube":60,"podcast":30,"x_video":1},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04736199\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"ARANOTE","nct_id":"NCT04736199","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=aranote-nct04736199. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"ARANOTE","arms":[{"description":"Participants will receive darolutamide 600 mg (2 tablets of 300 mg) twice daily with food and ADT of investigator's choice as standard therapy","label":"Darolutamide+ADT","type":"EXPERIMENTAL"},{"description":"Participants will receive placebo twice daily with food and ADT of investigator's choice as standard therapy","label":"Placebo+ADT","type":"PLACEBO_COMPARATOR"}],"collaborators":["Orion Corporation, Orion Pharma"],"completion_date":{"date":"2026-01-23","type":"ACTUAL"},"conditions":["Prostatic Neoplasms"],"enrollment":{"count":669,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Darolutamide (Nubeqa, BAY1841788)","type":"DRUG"},{"name":"Placebo","type":"DRUG"},{"name":"Androgen deprivation therapy (ADT)","type":"OTHER"}],"last_update":"2026-09-29","lead_sponsor":"Bayer","official_title":"A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2024-06-07","type":"ACTUAL"},"primary_outcomes":[{"measure":"Radiological Progression-free Survival (rPFS) Assessed by Central Review","timeFrame":"From randomization to the date when 222 rPFS events were observed, approximately 36 months"}],"references":[{"citation":"Saad F, Shore N, Vjaters E, Olmos D, Littleton N, Testa I, Mo M, Verholen F, Srinivasan S, Haresh KP. Darolutamide Plus Androgen-deprivation Therapy in Metastatic Hormone-sensitive Prostate Cancer by Disease Volume and Risk Subgroups in the Phase 3 ARANOTE Trial. Eur Urol. 2026 Aug 12:S0302-2838(26)02313-4. doi: 10.1016/j.eururo.2026.07.026. Online ahead of print.","pmid":"42586872","type":"DERIVED"},{"citation":"Morgans AK, Haresh KP, Jievaltas M, Olmos D, Shore ND, Vjaters E, Xing N, Mohamed AF, Littleton N, Srinivasan S, Verholen F, Saad F. Pain and health-related quality-of-life outcomes with darolutamide in metastatic hormone-sensitive prostate cancer (ARANOTE): secondary and exploratory analyses of a multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2026 May;27(5):614-624. doi: 10.1016/S1470-2045(26)00014-8. Epub 2026 Apr 9.","pmid":"41969015","type":"DERIVED"},{"citation":"Saad F, Vjaters E, Shore N, Olmos D, Xing N, Pereira de Santana Gomes AJ, Cesar de Andrade Mota A, Salman P, Jievaltas M, Ulys A, Jakubovskis M, Kopyltsov E, Han W, Nevalaita L, Testa I, Le Berre MA, Kuss I, Haresh KP; ARANOTE Study Investigators. Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial. J Clin Oncol. 2024 Dec 20;42(36):4271-4281. doi: 10.1200/JCO-24-01798. Epub 2024 Sep 16.","pmid":"39279580","type":"DERIVED"}],"start_date":{"date":"2021-02-23","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer","url":"https://clinicaltrials.gov/study/NCT04736199"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/aranote-nct04736199"}